Vasogen and Grupo Ferrer Form Collaboration to Commercialize Celacade(TM) in the European Union
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- Published on Thursday, 19 April 2007 04:00
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TORONTO, Canada | Apr 18, 2007 | Vasogen Inc. (NASDAQ:VSGND; TSX:VAS) today announced a collaboration with Grupo Ferrer Internacional, S.A. (“Ferrer”), a leading European pharmaceutical and medical devices company, to commercialize Vasogen’s Celacade(TM) technology for the treatment of chronic heart failure in the European Union and in certain Latin American countries. Under the agreement, Vasogen will receive 45% of Celacade revenues generated by Ferrer, as set out below, for a period five years from the date of first commercial sale on a country-specific basis, and will receive 42% of such revenues thereafter. Ferrer will be responsible for the costs associated with the launch and marketing of Celacade in Europe and certain Latin American countries. Vasogen will also receive milestone payments based on Ferrer’s achievement of first commercial sales of Celacade on a country-specific basis, and on reaching pre-specified sales thresholds. Chronic heart failure is a leading cause of morbidity and mortality throughout the western world and affects over 6 million people in Europe alone.
“Chronic heart failure is a major healthcare challenge in the industrialized world and this agreement represents a significant economic opportunity for our Celacade technology – a first-in-class therapeutic entrant,” commented Terry Gregg, President, Chief Executive Officer, and Chairman of Vasogen. “Given Grupo Ferrer’s proven ability to successfully introduce new healthcare technologies into the large markets of Europe and Latin America, we are extremely excited about this partnership and look forward to the initial commercialization of Celacade later this year.”
“Having followed the development of Celacade for several years, we are very enthusiastic about the opportunity for Grupo Ferrer to market this new immuno-modulatory strategy to the cardiology community of Europe and Latin America,” stated Dr. Carlos de Lecea, Vice President International & Business Development at Ferrer. “Celacade offers cardiologists an entirely new way to target the pathological inflammatory processes of heart failure not addressed by available therapies, and given the magnitude of the heart failure problem, we see a large economic opportunity for both Vasogen and Ferrer.”
Vasogen will host a conference call and web cast today (Wednesday, April 18, 2007) at 9:00 a.m. ET, to discuss the collaboration.
Interested parties are invited to participate by connecting 10 minutes prior to the start of the call to one of the following:
Direct Dial 416-695-6130
A re-broadcast of the conference call may be accessed by::
Direct Dial 416-695-6034
Pin code 3259#
Under the agreement, Ferrer will have the exclusive rights to market Celacade for the treatment of chronic heart failure and other cardiovascular conditions in specified countries of Europe, including Germany, Spain, Portugal, France, and Italy, and certain countries in Latin America, including Mexico, Brazil, Argentina, and Venezuela. Vasogen has already received European Union (EU) regulatory approval as a medical device under the CE Mark, which enables marketing of Celacade for the treatment of chronic heart failure in the 27 member countries of the European Union. Ferrer has also acquired the right of first negotiation with respect to the remaining countries of the EU. Under the agreement, the commercial launch strategy for Celacade in Europe will involve an initial commercialization phase during which Ferrer will target key opinion leaders in the major markets of Europe to ensure support for expanded use of Celacade within the broader cardiology community. Ferrer expects to commence the initial commercialization phase in the second half of 2007. Following the completion of the initial commercialization phase, Vasogen will receive 45% of Celacade revenues generated by Ferrer through the sale of Celacade single-use disposable cartridges, one of which is required for the delivery of each Celacade monthly treatment. After a period five years from the date of the first commercial sale on a country-specific basis, Vasogen’s share of the revenues will be 42%. Also under the terms of the agreement, Ferrer will be financially responsible for all costs associated with the launch and marketing of Celacade. Vasogen will receive milestone payments based on Ferrer’s achievement of first commercial sales of Celacade on a country-specific basis, and on reaching pre-specified sales thresholds.
Therapy utilizing the Celacade technology targets the inflammation underlying chronic heart failure and other cardiovascular diseases. Inflammation is a normal response of the immune system to cellular injury caused by infection, trauma, or other stimuli. During the inflammatory process, immune cells release a number of factors, including cytokines – potent chemical messengers that modulate inflammation and facilitate the healing process. While this inflammatory process is usually self-limiting, it can persist, become chronic, and lead to a number of serious medical conditions.
During a brief outpatient procedure, a small sample of a patient’s blood is drawn into Vasogen’s Celacade single-use disposable cartridge and exposed to controlled oxidative stress utilizing Vasogen’s proprietary Celacade medical device technology. Oxidative stress is a factor known to initiate apoptosis, a physiologic process that is inherently anti-inflammatory. The treated blood is then administered to the same patient intramuscularly. An initial course of treatment comprising three consecutive outpatient procedures is administered over a two-week period, and treatments are continued once per month thereafter.
About Grupo Ferrer Internacional, S.A.:
Grupo Ferrer Internacional is a privately held European research and commercial development based pharmacochemical and medical devices company headquartered in Barcelona, Spain. Ferrer operates today in over 60 countries with the overall aim to improve people's health and quality of life. Based on its policy of continuous expansion throughout the world, Ferrer has established strong industrial and commercial operations in Europe and has extensive commercial experience in Latin America, Africa, and in the Middle and Far East. Ferrer has licensing, distribution, and marketing agreements with large multinational pharmaceutical companies, as well as mid-size firms including AstraZeneca, Astellas, Johnson & Johnson, Merck Sharp & Dohme, Novartis, Roche, Sanofi-Aventis, Solvay, Cephalon, United Therapeutics, and The Medicines Co., among others.
In addition to its commercial operations, Grupo Ferrer operates pharmaceutical research and development facilities in Barcelona, Spain and Alsdorf, Germany. The research facilities in Barcelona manage all aspects of drug development from concept through to clinical development and product registration. The Alsdorf facility is specialized in new applications of pharmaceutical technology. Grupo Ferrer also has established research collaborations with a large number of pharmaceutical companies and universities throughout the world.
Vasogen is a biotechnology company engaged in the research and commercial development of therapies designed to target the destructive inflammatory process associated with the development and progression of cardiovascular and neurodegenerative disorders. The Company’s lead product, the Celacade(TM) technology, is designed to activate the immune response to apoptosis — an important physiological process that regulates inflammation. Celacade is in late-stage clinical development for the treatment of chronic heart failure and has received European regulatory approval under the CE Mark for this indication. Vasogen is also developing a new class of drugs for the treatment of certain neuro-inflammatory disorders and is preparing to advance VP025, the lead drug candidate from this new class, into phase II development.
SOURCE: Vasogen Inc.